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Abstracts - Monday June 21st 2004 1000-1130 |
Department of Anesthesia, Royal University Hospital, College of Medicine, University of Saskatchewan, 103 Hospital Drive, Saskatoon, SK, S7N 0W8
INTRODUCTION: Patient controlled epidural analgesia (PCEA) delivery systems permits labouring women to determine the amount and timing of epidural analgesic medication for labour pain relief. Although PCEA reduces the amount of epidural medication received by labouring women compared to continuous infusion epidural analgesia (CIEA) (1,2), there have been no studies of sufficient size to detect differences in obstetrical outcomes when PCEA alone is compared to PCEA + CIEA. Importantly, the impact of PCEA ± CIEA on the outcome of labour has yet to be properly evaluated using ambulatory epidural analgesics (3). Therefore, the purpose of this prospective, randomized, double-blinded study was to compare the impact of PCEA vs PCEA + CIEA, using ambulatory labour analgesia, on the incidence of cesarean delivery (C-D) and instrumented (forcep or vacuum) vaginal delivery (IVD).
METHODS: This study was conducted between Jan 2000 and Dec 2003. Following IRB approval and written informed consent, 300 nulliparous women undergoing induced labour, determined to be in established labour, <6 cm dilated and requesting labour epidural analgesia (LEA) were randomized. LEA was established with 20 ml of 0.8% Ropiv + 2 µg/ml Fent (3), with each woman then randomized to receive this same analgesic solution either via PCEA (5 ml bolus; 10 min lockout, No 4 hour limit) alone or PCEA (5 ml bolus; 10 min lockout, No 4 hour limit) plus CIEA (10 ml/hr) in a double-blind manner to maintain LEA. LEA and obstetric management were predetermined using strict protocols. Data was analyzed using an intent-to-treat model, major protocol violations (MPV) excluded. Data analysis included 2-tailed T test with P<0.05 considered significant.
RESULTS: 150 women were randomized in each group with no statistical differences in demographics, method of labour induction, cervical dilatation at time of LEA, gestational age, VAS pain scores prior to LEA and neonatal weight. Several MPV were identified in each group including 9 PCEA (1 "wet tap"; 8 epidural catheter replacements) and 6 PCEA + CIEA (1 "wet tap"; 3 epidural catheter replacements; 1 undiagnosed breech in 2nd stage; 1 PCEA pump programmed incorrectly). Therefore, the treatment allocations were administered to 141 women in the PCEA group and 144 women in the PCEA + CIEA group. Women in the PCEA group received significantly less epidural Ropiv (45.2 ± 34.1 mg) compared to PCEA + CIEA (78.6 ± 39.9 mg) P<0.0001. There were no statistical differences in the duration (min) of the 1st stage of labour with PCEA (414 ± 249) and PCEA + CIEA (455 ± 254) and 2nd stage with PCEA (127 ± 86) and PCEA + CIEA (144 ± 114) or incidence of C-D with 37 PCEA (26.2%) and 37 PCEA + CIEA (25.7%), IVD with 43 PCEA (30.5%) and 48 PCEA + CIEA (33.3%), or neonatal pH <7.20 and APGARS <7.
DISCUSSION: LEA using 0.08% Ropiv + 2 µg/ml Fent delivered by PCEA alone and PCEA + CIEA (10 ml/hr), provides effective analgesia throughout labour. Although, PCEA alone significantly reduces the amount of ambulatory epidural medication parturients receive during labour, our investigation did not identify any benefit to utilizing PCEA alone with regard to labour or neonatal outcome.
REFERENCES:
3 Anesth Analg 90: 13849, 2000
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